COSOPT-S® Treatment Versus Acetazolamide Before Trabeculectomy

NCT ID: NCT01228149

Last Updated: 2017-08-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2014-04-30

Brief Summary

The most common cause of post-trabeculectomy filtration failure is postoperative scarring. Long-term preoperative treatment with local antiglaucoma agents containing preservatives has an increased risk of post-operative scarring of the filtration bleb. Therefore many surgeons prepare their patients for planned trabeculectomy by discontinuing local antiglaucoma drugs, controlling IOP with oral acetazolamide, and treating the eye with local steroids.

Preservative-free COSOPT-S® eye drops b.i.d now provide a possibility to reduce IOP preoperatively with the aim of avoiding postoperative excessive scarring and the known adverse effects of oral acetazolamide while achieving comparable IOP reduction and long-term outcomes.

This study will investigate comparability (non-inferiority) of medical benefits of two different IOP lowering pharmaceutical interventions prior to trabeculectomy comparing COSOPT-S® bid to oral acetazolamide plus dexamethasone.

Detailed Description

The most common cause of post-trabeculectomy filtration failure is postoperative scarring. Long-term preoperative treatment with local antiglaucoma agents containing preservatives has an increased risk of post-operative scarring of the filtration bleb. Therefore many surgeons prepare their patients for planned trabeculectomy by discontinuing local antiglaucoma drugs, controlling IOP with oral acetazolamide, and treating the eye with local steroids.

Preservative-free COSOPT-S® eye drops b.i.d now provide a possibility to reduce IOP preoperatively with the aim of avoiding postoperative excessive scarring and the known adverse effects of oral acetazolamide while achieving comparable IOP reduction and long-term outcomes.

This study will investigate comparability (non-inferiority) of medical benefits of two different IOP lowering pharmaceutical interventions prior to trabeculectomy comparing COSOPT-S® bid to oral acetazolamide plus dexamethasone.

Conditions

Glaucoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Diamox/DexaEDO

Patients receive Diamox (oral acetazolamide) starting 28 days Prior to trabeculectomy. 7 days preoperatively DexaEDO (dexamethasone) eyedrops without preservatives are applied additionally. Patient will undergo trabeculectomy.

Group Type: ACTIVE_COMPARATOR

Trabeculectomy with preoperative Diamox/DexaEDO treatment

Intervention Type: DRUG

Filtrating glaucoma surgery, preoperative treatment with Diamox (acetazolamide) 28 day prior surgery. DexaEDO (dexamethasone) 7 days prior surgery

Cosopt S

Patients receive Cosopt S (dorzolamide/timolol) eye drops starting 28 days before trabeculectomy.

Group Type: EXPERIMENTAL

Trabeculectomy with preoperative Cosopt S treatment

Intervention Type: DRUG

Filtrating glaucoma surgery, preoperative treatment with Cosopt S (dorzolamide/timolol) 28 day prior surgery.

Interventions

Trabeculectomy with preoperative Diamox/DexaEDO treatment

Filtrating glaucoma surgery, preoperative treatment with Diamox (acetazolamide) 28 day prior surgery. DexaEDO (dexamethasone) 7 days prior surgery

Intervention Type: DRUG

Trabeculectomy with preoperative Cosopt S treatment

Filtrating glaucoma surgery, preoperative treatment with Cosopt S (dorzolamide/timolol) 28 day prior surgery.

Intervention Type: DRUG

Other Intervention Names

Filtrating glaucoma surgery; Filtrating glaucoma surgery

Eligibility Criteria

Inclusion Criteria

• Male or female patients aged 18 years or older
• Caucasian
• A clinical diagnosis of open angle glaucoma, pseudoexfoliation or pigment dispersion glaucoma, or ocular hypertension in one or both eyes
• Planned trabeculectomy
• Previous treatment with antiglaucoma agents containing preservatives for at least one month
• Best corrected visual acuity of 20/800 or better in the study eye

Exclusion Criteria

• Secondary glaucoma except pseudoexfoliation glaucoma and pigmentary glaucoma
• Current ocular infection, i.e. conjunctivitis or keratitis
• Any abnormality preventing reliable applanation tonometry
• Intraocular surgery or laser treatment within the past three months
• History of surgery involving the conjunctiva
• History of cataract surgery with sclerocorneal approach
• Subject is allergic to sulfonamides
• Reactive airway disease, including bronchial asthma or a history of bronchial asthma, or severe chronic obstructive pulmonary disease
• Sinus bradycardia, second or third degree atrioventricular block, overt cardiac failure, cardiogenic shock
• Severe renal dysfunction (CrCl < 30 ml/min) or hyperchloraemic acidosis
• Depressed blood levels of sodium and / or potassium
• Marked kidney and liver disease or dysfunction, gout, suprarenal gland failure, hypercalciuria or nephrocalcinosis
• History of hypersensitivity to the investigational medicinal products or to any drug

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Katrin Lorenz

OTHER

Sponsor Role: lead

Responsible Party

Katrin Lorenz

MD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Katrin Lorenz, MD

Role: PRINCIPAL_INVESTIGATOR

Johannes Gutenberg University Mainz

Locations

Clinical Trial Site, Department of Ophthalmology, University Medical Center Johannes Gutenberg University Mainz

Mainz, , Germany

Countries

Germany

Other Identifiers

35131; EUDRA CT 2010-019975-30

Identifier Type: -

Identifier Source: org_study_id